Tuesday, March 20, 2007

The Blame Game

Great. Now doctors and nurses are responsible for rising hospital charges?

Hospital costs sneak up as economy humsWage increases blamed, but some seek more protection for needyTan Hui LengDON'T like the heftier numbers on your hospital bill? Blame the economy. Apparently, it is doing too well.

Almost every hospital in Singapore has raised its charges — admittedly by just a handful of dollars. As the demand for healthcare professionals rises with the improving economy, hospitals' manpower costs are going up.

Noting that the majority of healthcare costs goes to human resource, National University of Singapore health economist Associate Professor Phua Kai Hong said: "Every time there is a wage increase, the first to be affected is healthcare because there are many qualified specialists there and you need to keep them from moving to the private sector."

It is not the specialists alone that are benefitting. Nurses have been asked to shoulder some of the responsibilities of junior doctors. But this came with a demand for better benefits, and they recently got a pay hike.

Health Minister Khaw Boon Wan said in Parliament two weeks back that his Ministry had to keep wages competitive to hold on to qualified professionals like nurses and speech therapists. "This is also the reason why medical fees need to be raised periodically as the cost of manpower is a major component of medical costs," he said.

But patients see only the bottomline — and they don't always like what they see.

At Singapore General Hospital (SGH), subsidised inpatients in Class B2 wards will pay $53 a day — an extra $3, or 6 per cent more — from April. Those in Class C wards will pay $26 a day, $1 more than they currently do.

SGH said that the increases are its first since 1993.

An SGH spokesman said that even though its expenses had risen steadily, the hospital had held off any fee increase until now.

And even with the hike, the hospital will recover "just a small fraction" of its rising costs, said chief executive Prof Tan Ser Kiat.

"With an increasing volume of subsidised patients, and facilities at SGH which need updating, any under-collection of revenue would mean fewer resources available for meeting the growing need for improvements necessary for sustaining quality of patient care," he said.

At National University Hospital, the accident and emergency (A&E) fee was increased from $70 to $80 in January — the hospital's first A&E fee hike since 1997.

At Alexandra Hospital, C-class ward charges went up from $21 to $23, subsidised specialist outpatient clinic consultation rates went up from $18 to $20, while A&E went up from $55 to $60; all increases took place late last year. At KK Women's and Children's Hospital, ward treatment fees also increased from last month.

Only Tan Tock Seng Hospital and Changi General Hospital have not raised their fee and now all eyes are on them.

The hospitals, themselves, did not want to comment, but NUS economist Prof Phua felt it was only a matter of time before their fees went up. "These are government hospitals, so they'll follow suit," he said.

Despite the hospitals and the Ministry offering their reasons for the hike, Dr Lam Pin Min, MP and Deputy Chairman of the Government Parliamentary Committee for Health, said he was somewhat surprised. "I was a bit shocked to see the fee revisions for the different hospitals," Dr Lam told Today.

"The timing is not very appropriate — why is there a need to increase prices when the GST hike has just been announced?"

The Government has already said that it will absorb the Goods and Services Tax hike for all subsidised patients. But, Dr Lam pointed out, that is just a two-percentage-point hike, whereas the recent rise in consultation and hospital fees appeared to be more substantial.

The Health Ministry said that the fees would remain affordable to all subsidised patients and the needy would not be denied care.

NUS health economist Prof Ake Blomqvist added that, by international standards, hospital charges in Singapore were not particularly high, especially given the quality of healthcare.

"And if there is concern about the burden that an unexpected major illness sometimes places on low-income people with limited Medisave balances and little medical insurance coverage, it is probably better to work on strengthening the safety net for those population groups specifically, rather than increasing the subsidy to all health care users, including high-income ones," he said.Certainly wages make up a significant proportion of a healthcare cluster's annual expenditure (just a little more than 50% in both clusters - see here and here), but this is not surprising for a business where the chief commodities being sold are knowledge and skills and not goods.Moreover, manpower cost is not the only part of the expenditure that is rising (nor the component that has seen the biggest percentage rise - do look through the annual reports for the past few years; you may be surprised...), nor are doctors and nurses the only ones on the payroll.To single out wage increases for 'specialists' and nurses in the article and to just gloss over the other factors contributing to an increased expenditure is to do these people a disservice.

Patients should feel relieved that public hospitals and doctors are not recognised first and foremost for the number of private patients they bring in, and that institutions like the National Neuroscience Institute (NNI) always accord quality of patient care the first priority.

We should recognise, though, that not every health plan, hospital, doctor or nurse gives high quality care. Quality varies, for many reasons.

Quality healthcare means doing the right thing, at the right time, in the right way, for the right patient.

In public hospitals, the waiting time to see a specialist is generally long, while the time spent in consultation with a doctor is usually very short — maybe five to 10 minutes.

In the process of delivering patient care, doctors must look through a patient's history, then check the patient and prescribe a treatment plan in the presence or absence of a nurse. Under such circumstances, how would the hospital know the level of quality of patient care delivered by their doctors?

How is healthcare quality measured? How are patient satisfaction and treatment and prevention of an illness measured? How are errors detected and rectified?

Generally, subsidised patients are assigned to junior doctors. If they are lucky, they may get to see a senior doctor. Private patients, if they do not specify the doctor of their choice, are assigned to a senior doctor automatically. In addition, they enjoy shorter waiting times.

Ideally, healthcare should be non-discriminatory, providing the same quality of service regardless of race, ethnicity, age, sex, health and financial status. However, it is common knowledge that private patients enjoy better facilities and services than subsidised patients.

By and large angry doc acknowledges the concerns raised by Mr Goh. They are relevant to all 'stakeholders' in the healthcare partnership: doctors, patients, and administration.

However, angry doc makes a distinction between the quality of healthcare provided and the quality of service provided.

angry doc cannot deny that private patients may enjoy better facilitites and *services* than subsidised patient, and that these advantages (shorting waiting time, longer consultation time, ability to afford more expensive drugs and treatment) do translate to better care, but that does not mean that subsidised patients receive low-quality *care*.

How do we measure the quality of care then?

Well, it depends on whose angle you are looking at it from, doesn't it?

Mr Goh gives a good definition: "Quality healthcare means doing the right thing, at the right time, in the right way, for the right patient."

But even if we can all agree on this definition, one can easily imagine the difficulty we will have in agreeing on what 'the right thing', 'the right time', 'the right way' and 'the right patient' mean. We can try to be objective, we can track objective data like waiting times, costs, clinical parameters and so on, but unless we can agree on what constitute 'right-ness', we will just be gathering a lot of data and not convincing anyone.

Healthcare being a confidence goods, angry doc prefers to rely on the good old-fashioned concept of medical paternalism, and a 'separation of powers': a discerning patient may be the best judge on quality of *service* received, but a good doctor will be the best judge on the quality of *care* delivered. He is not quite sure where the administrator comes in though...

Monday, March 19, 2007

Tough Club

There are a few select words that can always make angry doc cringe when he reads them, and 'holistic' is one of them. Hence his attention was drawn to this piece of news; surely, he asked himself, teachers aren't going to start teaching students how to balance their 'qi' in school, are they?TAF programme evolves into "Holistic Health Framework" for studentsSINGAPORE : The Trim and Fit (TAF) programme in schools is moving on.The programme has been credited for making a vast improvement in the physical fitness level of students here.Implemented 15 years ago, the TAF programme has evolved into what is called the "Holistic Health Framework".According to the Education Ministry, the new framework will take into account the total well-being of each and every student.The TAF Programme has been successful since it was implemented in 1992.But being healthy is not just about being physically fit.And that is why the new "Holistic Health Framework" will look at a student's physical, mental and social health.The Education Ministry hopes that this new approach will motivate students to continue with a healthy lifestyle, even after leaving school.So schools will be given time to develop the different aspects of this new push.Masagos Zulkifli, Senior Parliamentary Secretary, Education, said, "MOE will work closely with schools to help them set (in place) their processes for (the) total health of our students... over the next three to four years."This period of about three years will provide schools time as we recognise that each school is at a different stage of progress and level of readiness in the area of health promotion. We will want to see every school come on board the 'Holistic Health Framework' by 2010."Mr Masagos was speaking at the annual TAF Award Ceremony, which recognises schools for their efforts and their achievements in keeping their students trim and fit.And from next year, to match the new programme that will replace TAF, schools will receive a different award for their health promotion efforts.The Health and Promotion Board and the Education Ministry will be jointly giving out the "Championing Efforts Resulting in Improved School Health" or CHERISH award.Meanwhile, to recognise the efforts of Junior Colleges and Centralised Institutes in promoting physical fitness, the final year students from these institutions received the Mindef Physical Fitness Awards (MPFPA). From the offical press release, angry doc learns that:"The thrust of HHF [Holistic Health Framework] is the total well-being of each student. In line with this, schools’ health promotion efforts will now include physical, mental and social health. Opportunities will be given to students to develop the skills and attitudes to live healthily and sustain a healthy lifestyle even after they leave school."

"Schools adopting the HHF are distinguished by the following key components:

Supportive School Culture and Organisation

A supportive school culture and organisation is demonstrated by having a shared vision on health which culminates in an action plan for effective delivery and resource building.

Comprehensive and Relevant Formal and Non-Formal Curricula

A comprehensive and relevant formal and non-formal curricula is [sic] the main vehicle in the delivery of holistic health.

Synergistic Collaborations and Partnerships

Synergistic collaborations and partnerships with stakeholders supporting schools’ health promoting efforts through the sharing of expertise and resources."Good grief. It used to be we just gave schools money for picking out the fat kids and making them run laps after school, which was fine by angry doc, because fat kids creep him out.angry doc is quite sure the Ministry has good intentions, but the terms of reference are really vague. Who will define the standards of 'physical, mental and social health'? Will schools actively find cases? What are the local, institutional, and community resources available?The most important question is: how will it impact the children?As it is angry doc has seen children so distressed by being included in the 'TAF club' that their parents tried to obtain a medical reason for them to be exempted from it - it was one thing to be teased by your classmates for being fat, and another altogether to be labelled so by the school. Will children now be included in a 'HHF club' for not meeting the required standards of 'physical, mental and social health'? I hope not.

Saturday, March 17, 2007

Well Wishes

Say what you want about my friend Al, but you can't fault his good intentions...Al: Let's go to the wishing-well again.angry doc: Er... for what?Al: I want to make a wish for that charity that's having a fund-raiser this weekend; I hope they'll raise lots of money to help all those poor people.

angry doc: There's no plausible reason why throwing a coin into a well should influence how well a charity does, especially since that charity does not get the money from the well.Al: Ah, but remember the last time I wished that charity well, and they raised a few million dollars in donations?

angry doc: Yes, but that was because they had a fund-raiser that weekend. You can't know that it was your wish at the well that made them raise all that money. Besides, remember that time you wished the other charity well, but they got investigated and was suspended from raising funds for a few months instead?Al: I can't say I do. Or maybe it was because I didn't throw enough coins into the well.

angry doc: That's an interesting theory. How do you suppose to find out just how many coins would be enough?Al: Lend me a thousand bucks.angry doc: Why?Al: I'm going to get a thousand dollars worth of coins so I can throw them into the wishing-well to see if that's enough to help that charity raise funds.

angry doc: Er... if you are so keen to help that charity why don't you just give the thousand dollars to them instead?Al: You're not much into science, are you?

One Life Saved? 2

As we move more and more towards the idea of patient-autonomy, patient-education becomes a more important part of our role as doctors. angry doc believes that patient-education must go beyond feeding patients with facts; we must teach patients how to look at arguments pitched at them and decide for themselves whether they should be persuaded by certain health claims and information regarding the healthcare system and their health. Letters like this one don't help. Cardiac arrest: Stick to chest compressionsDR ANDY Ho raised a few heartbeats with his article, 'CPR may not be the best option' (ST, March 12), on the value of cardio-cerebral resuscitation (CCR) versus cardio-pulmonary resuscitation (CPR).

I wish to relate a real-life experience during the Prime Minister's National Day Rally at the Kallang Indoor Stadium in 1988, when Mr S. D. Maniam collapsed, followed by fits and loss of consciousness. I was seated a few rows behind him when I realised he was in cardiac arrest.

He was pulseless and I immediately started rapid chest compressions. He survived. He was later taken to hospital, where an ECG confirmed an acute heart attack. A coronary angiogram done later confirmed severe coronary-artery disease. He then underwent successful triple-vessel coronary-artery bypass surgery.

Today, 19 years after CCR and subsequent definitive therapy, Mr Maniam is hale and hearty.

The heart-warming moral of this 1988 experience: CCR is the best modality of treatment in a cardiac arrest.

There has been plenty of discussion on the effects and methodology of CPR versus CCR.

The time-honoured CPR underwent dramatic changes from the initial five to two, meaning five chest compressions to two mouth-to- mouth respiration (occasionally mouth-to-nose respiration), about four decades ago, to 15 to two, and, recently, 30 to two, and, now, 100 to zero, meaning 100 chest compressions to zero or no mouth-to-mouth respiration.

The compressions remain at 11/2 to 2 inches, or 4 to 5 cm depth.

In my humble opinion, Singapore should change the guidelines, to do CCR for all cardiac-arrest patients at a rate of roughly 100 compressions per minute till definite medical help arrives. This will certainly save more lives.

Interruption of chest compressions even for a few seconds, such as to do mouth-to-mouth respiration, will impede blood flow to central circulation, such as the heart and the brain. Moreover, CCR will save one from getting incidental cross infections.

With enough proof from the United States and Japan, which saw an enhanced survival rate of 300 per cent with CCR, this methodology must be seriously considered.

However, CPR still has a place for resuscitation of the lungs in cases of drowning or drug overdose.

Dr V. P. Nair Consultant cardiologistI hope Dr Nair doesn't really expect us to change our resuscitation protocol based on his one successful use of CCR, because angry doc can certainly quote more than one instance where CPR has been successful. Science just isn't done like that, Dr Nair. Frankly, angry doc thinks the letter would have been more convincing had Dr Nair omitted his anecdote. Is CCR better than CPR? Certainly there is evidence that CCR is better than CPR for out-of-hospital cardiac arrests. This Medscape interview tells us more about CCR. The situation is more complex in the context of training large numbers of the lay public to perform resuscitation in the out-of-hospital setting. CCR is designed only for unexpected, witnessed, cardiac arrests. Will laymen be able to decide when CCR is indicated, and when CPR would be more appropriate? After all, it has been shown that laymen often have difficulty feeling the pulse of a collapsed victim. Or does it matter, since it has also been shown that many of them do not perform mouth-to-mouth ventilation anyway? There will probably be more debate and discussion on the issue before Singapore decides if we should change our protocol for the lay public. Whatever the case, I can tell you something: doing 200 chest compressions in 2 minutes can be really hard on your arms.

Mental Capacity Act 2

The capacity to ease sufferingProposed legislation – if properly enacted – could solve many problems for mentally-incapacitated

THOMAS KOSHY

A WOMAN lies mentally incapacitated by a stroke a day after delivering her newborn child. Her distraught parents take the new mother home to care for her. Later, when her husband wants her back, a "tug-of-love" ensues between parents and husband.

Eventually, the matter goes to court for a decision on who has the right to decide where she should live.

This was a real-life scenario in Singapore five years ago, and the High Court's ruling — in favour of the husband — was finalised only three years later.

Now, a piece of legislation proposed last week in Parliament by the Minister for Community Development, Youth and Sports, Dr Vivian Balakrishnan, may pave the way for families to avoid such uncertainty.

The Mental Capacity Act (MCA), according to his ministry, is meant to "help Singaporeans plan ahead to ensure their personal and financial well-being in the event that they lose their mental capacity to conditions such as dementia, traumatic brain damage and stroke".

Currently, it is only after mental incapacity manifests in a patient that a court may appoint a representative to make decisions for him or her.

The MCA will allow individuals to designate a representative beforehand, and the requirement for an application to court may also be removed.

The advantages are obvious: Simplicity and certainty.

Simplicity in doing away with cumbersome court applications. Certainty in knowing that the wishes of the patient are being honoured. After all, in the absence of a nomination, a court can only guess whom the patient would have appointed as his representative.

One question is what bearing the MCA will have on the Advance Medical Directive (AMD) Act. Unlike a living will, an AMD currently is a standard form which does not allow individuals to specify in any detail which medical procedures they would rather not undergo.

The AMD Act may benefit if individuals could specify in greater detail than they are currently allowed to, through a living will, which medical procedures they would rather not undergo.

With the introduction of the MCA, would the appointed representative have the authority to decide whether certain courses of medical treatment should be pursued? If so, such a representative could be akin to an autonomous "living will" of the mental patient.

Would that then mean the representative has the right to revoke the patient's AMD or to opt the patient out of the Human Organ Transplant Act (Hota)?

The drafters of the MCA will have to decide the parameters of the directions a patient may leave to an appointed representative, and when specifically these powers are transferred over. Would some sort of mental illness be a pre-requisite or would unconsciousness be an adequate trigger?

Simple issues like the definition of "mental incapacity" and specification of the circumstances in which a person may revoke or alter his choice of representative can also present fundamental challenges.

Individuals should not be left with a lingering fear that they may end up trapped in a nightmare scenario of being unable to alter their choice because they are deemed not to have the mental capacity to do so.

Leaving the assessment of mental capacity to another person always leaves open the possible peril of being found mentally incapable even though the patient himself feels fine.

When all is said and done, though, one suspects that the biggest obstacle to the efficacy of the proposed MCA will be simply getting people to use it. It is quite likely the MCA may go down the same avenue as the AMD Act, which was enacted a decade ago but has had only about 4,000 takers.

Would it be feasible to have a system whereby, for example, all persons reaching the age of majority have to be informed in person of the various issues that each individual should ideally address — including whether to opt out under Hota, whether to execute an AMD and whether to appoint a representative under the proposed MCA.

A formal procedure would help Singaporeans think critically about these end-of-life and caregiver issues.

The proposed MCA will be a boon to Singaporeans as it gives them greater choice. Practically speaking, though, what is more important is whether that choice is exercised or lies buried in the law.

Wednesday, March 14, 2007

The art of replying to complaint letters

Fascinating. Yesterday we featured Ms Lai's letter to the ST Forum on how her mother could not get an early appointment as a subsidised patient, but was offered an appointment the next day if she would become a private patient.She asked: 'Does this mean that NHC would rather let an appointment slot reserved for private patients go unused than let a subsidised patient utilise the slot?' The reply from the hospital is published in the ST Forum today. In this letter Dr Chua takes us through the number of referrals NHC receives each month, their system for triaging referrals, and the rationale behind it. He does not actually answer Ms Lai's question.What really impressed angry doc, however, is Dr Chua's use of a single word which quite frankly could have been omitted, but whose inclusion put a sting in the reply. I emphasise the word in the letter which is reproduced below:Earlier appointments for patients due for opI REFER to the letter, 'Offer available 'private' slots to subsidised patients' (ST, March 9), by Ms Lai Howe Ling.

The National Heart Centre (NHC) receives requests for over 1,200 new outpatient referrals per month, a more than four-fold increase since it was established in 1994.

To cope with this high demand, NHC implemented a system for providing appointments, based on the urgency of the medical condition of the patients.

For patients with acute chest pain or suspected heart attack, our doctors work with the A&E Department to provide a 24-hour emergency angioplasty service to all patients, regardless of class.

For patients who do not have a cardiac emergency, but require earlier appointments because of suspected heart disease or the need for assessment prior to surgery, we routinely provide priority 'fast track' appointments within 2-3 weeks, based on the urgency and the date of surgery, as requested by the referring institution, and regardless of the patient's class.

Other patients who do not have such urgent requirements are given routine appointments.

According to our records, Ms Lai's mother was referred by the polyclinic to NHC for asymptomatic ECG findings, hence a routine appointment was given.

(A recent study by NHC showed that for patients with such findings, the likelihood of significant heart disease was very low.)

We were initially not aware that the patient was going for an eye operation at a private hospital, otherwise an earlier appointment before the operation date would have been given.

Subsequently, when Ms Lai contacted us, our staff overlooked the possibility of using the priority appointment system for pre-operation assessment. (Normally the hospital doing the operation would call our staff for an early appointment).

We apologise for this lapse. We have contacted Ms Lai and were informed that her mother is fine and would be going for the eye operation at the end of the month.

We would like to highlight that it is not our policy to request patients to upgrade their class status to get an earlier appointment date, as there is a system to ensure fast-track appointments for subsidised patients for urgent referrals and pre-operation assessment.

Friday, March 09, 2007

Mental Capacity Act

YOUR mind is still sharp and you have friends and relatives that you can trust. But what if dementia strikes, the thinking gets muddled and you are left helpless in the care of someone who doesn't particularly care for you?

The Government is exploring a new law that would enable individuals to appoint, in advance, someone to take charge of their personal well-being and financial affairs, should they be incapacitated by dementia or some other mental illness.

Broaching this tentative Mental Capacity Act (MCA), the Minister for Community Development, Youth and Sports Dr Vivian Balakrishnan told Parliament that it was better for Singapore to prepare for an ageing population.

This is a truth that lawyer Navin Lobo has seen underscored all too frequently.

He has seen enough tears and dirty linen aired when family members go to court to fight over who should be appointed to care for a mentally disordered person and manage his or her affairs.

"It gets messy and people end up getting hurt," the lawyer from Harry Elias told Today.

The tussle gets worse if there is money involved.

A family member appointed by the court to look after a mentally-ill man emptied his bank account and did away with his property. There wasn't even enough money to take care of his day-to-day expenses and she told other relatives to chip in.

In some cases, persons appointed by the court may not always have take decisions the best interest of the patient, said Mr Lobo. In other cases, the level of care provided could be indifferent.

Such situations can be averted if individuals, themselves, can decide what happens to them and their affairs before they lose their mental capacity.

Currently, under the Mental Disorders and Treatment Act, the High Court can appoint someone only after the person has lost his or her mental capacity.

The Ministry is studying similar laws enacted overseas in Britain, Germany and Hong Kong.

For instance, Britain's version of the MCA provides for a lasting power of attorney, which gives someone the right to make decisions on your behalf about things like your personal welfare and healthcare, as well as property and money. Financial decisions can be taken even before the illness strikes, but this person can take decisions about personal matters only after you lose your mental capacity.

Giving the thumbs-up to this proposal was Ms Cho Peilin, who works in public relations. She said that having something like the MCA could avert the bind she faces as caregiver to her aunt, who is in her 80s, unmarried and suffers from dementia.

Relatives were worried about inviting allegations of fraud after Ms Cho suggested that the family to go through her aunt's finances to work out a financial and healthcare plan for the elderly woman.

Vice-president of the Autism Resource Centre Loh Wai Mooi, who also welcomed such an Act, also hoped for a Code of Practices to be drawn up as minimum standards that MCA appointees have to abide by.

Dr Balakrishnan said that the Ministry will conduct "extensive" consultation with the public and related organisations to ensure that "we have a system that protects and safeguards the interests of the mentally incapacitated".

The draft Bill is expected to be ready by May and consultation will start after that.

angry doc wonders how we've managed to muddle through this issue without such a law all these years.Anyone who has had to care for a 'mentally incapacitated' patient with a complex family dynamics can tell you it can be a nightmare; oftentimes the patient becomes more of a battleground fought over by the relatives than a person to be cared for. How should the doctors decide which party's decision over the patient's management to respect?While this proposed bill may not end fighting amongst family members, it will make things easier for the healthcare and social service workers managing the patient's case.You can find out more about UK's Mental Capacity Act here.

Thursday, March 08, 2007

Quackbuster: Singapore 5

This interesting piece of news illustrates to angry doc why quackbusting may not be such a straightforward job after all...

Consumers warned against taking illegal medicinal productsSINGAPORE: The public has been advised not to buy unlicensed health products that claim to improve sexual health, impotency or have aphrodisiac properties. They may contain a potent drug called sildenafil which can cause serious side effects. These include sudden vision loss, increased heart rate and decreased blood pressure in certain susceptible individuals. It may also cause fatal consequences in patients with heart conditions, especially those who are taking medicines containing nitrates for the treatment of their heart condition.The Health Sciences Authority (HSA) said sildenafil should only be prescribed by a medical doctor and taken under strict medical supervision because of its potential serious side effects. It issued this warning after an illegal medicinal product called Urat Madu was found to contain the drug. The product, which is touted to have aphrodisiac properties, is not licensed by HSA. A sample was obtained from a member of the public who had bought the product from overseas. The product was found to contain sildenafil upon testing. Sildenafil is a substance controlled under the Poisons Act. Sounds dangerous, doesn't it?Now those of you who don't already know what sildenafil is, do google it up.Now tell me every hot-blooded male in town isn't going to try and get their hands on some Urat Madu.

Wednesday, March 07, 2007

NUMB3RS

He would like to say it's because it has got all those funky mathematical models in it, but he suspects the real reason is because he find Jewish men sexy. We all use math every day. We use maths and numbers in medicine in ways that angry doc confesses he does not understand.

An anonymous commentor drew angry doc's attention to a study led by a mathematician, which looked at the data from a major heart study using a novel mathematical model, and concluded that the relationship between blood pressure and mortality is not linear as was commonly believed. It does not conclude, as the commentor does, that 'there is no evidence whatsoever that lowering blood pressure has any effect on CHD.' angry doc does not understand the complex mathematical model used in the analysis, but he did managed to find this medscape article to help him understand it.

The sixth report of the Joint National Committee on the Detection, Evaluation, and Treatment of Hypertension (JNC VI), the World Health Organization (WHO), and the International Society of Hypertension (ISH) all accept and promote the concept that there is a strong, continuous, and linear relationship between increasing systolic blood pressure, cardiovascular risk, and overall mortality.

Additionally, these expert groups feel this risk becomes unacceptable at 140 mm Hg and, therefore, therapy should be initiated regardless of either age or gender at this level of pressure. This concept has now been challenged by a group of statistician investigators from southern California.

Reassessing the first 18 year Framingham data, the investigators constructed a mathematical model after arranging systolic pressure by deciles (10%-90%), age groups (45-54, 55-64, and 65-74), and gender. The new mathematical model, called a reduced horizontal logistic spline, assumes two curves, one to the left of a predetermined set point (called "the knot") and a second curve to the right. They used death as their end point, not stroke or heart attack, which was evaluated in the Framingham study. This more complicated model showed no increase in the risk for death up to at least the 70th decile of systolic blood pressure ("the knot"), an increase began between the 70th and 80th decile, and a steep increase thereafter. Furthermore, this analysis was both age and gender-specific, with elderly women tolerating higher systolic pressures than younger men. Using this model, when men were compared against women, it is suggested that hypertension need not be treated until a threshold systolic blood pressure exceeds 159 mm Hg vs. 167 mm Hg in those 65-74 years of age, 148 mm Hg vs. 158 mm Hg in those 55-64 years of age, and 141 mm Hg vs. 142 mm Hg in those 45-54 years of age, in men and women respectively.

We continually hear how poorly blood pressure is being controlled, as the most recent guidelines suggest we should reduce systolic blood pressure to 140 mm Hg or lower. Along comes this mathematical analysis suggesting that we are unnecessarily treating many patients.

If accepted, these suggested criteria would have a major impact on the number of elderly patients who would be treated for systolic hypertension. By their estimates, the authors state that although 22% of men and 40% of women, 65-74 years of age, would meet current criteria for treatment (>140 mm Hg), they would fall to the left of "the knot" and, therefore, would not meet the suggested threshold of systolic pressure that merits treatment. As the public health implications of these two strategies are enormous, a number of important clinical points should be raised when critically reviewing this study. The present study only used the first 18 years of the Framingham data because in the earlier study years "the study was little affected by antihypertensive drug intervention," even though there is more robust 40 year follow up data from Framingham. Previous analysis of this same data used a linear logistics regression model, which was supported by the vast mix of evidence from multiple epidemiological and clinical trials. This is the first exposure most clinicians have had to the logistic spline model, which lacks not only clinical evidence of support, but biologic plausibility as well. Finally, these statisticians have ignored stroke and heart attack in their analysis and have only evaluated mortality because it was "free of misclassification." The clinical problem we all face, however, is that our patients will benefit by preventing both stroke and cardiovascular events and not just preventing death.

If we accept the present analysis suggesting that we reduce systolic pressure to 155 mm Hg in men and 167 mm Hg in women, aged 65-74 years, we will ignore the Systolic Hypertension in the Elderly Program (SHEP), which demonstrated a marked reduction in stroke and cardiovascular event rates with systolic blood pressure reduction to 143 mm Hg as opposed to 155 mm Hg in the placebo group.

Decisions regarding usefulness of treatment should be based on clinical trials evaluating both morbidity and mortality. Therefore, we should continue to use current guidelines in the treatment of hypertension. For now, we should reduce systolic blood pressure to <140 mm Hg and watch for additional trials that address the issue raised by this study.

There is always the danger in medicine of drawing a conclusion from just one study and taking that as the truth.The study looked at *parts* of the data from one study (albeit a big one) and looked only at death as an end point. It certainly does not allow one to conclude that 'there is no evidence whatsoever that lowering blood pressure has any effect on CHD', which does not always end in death.Certainly we are now realising that there may be factors other than blood pressure which determine cardiovascular risks, but angry doc is not yet convinced that blood pressure has nothing at all to do with them, especially when the current evidence continue to show a relation between blood pressure and risk of cardiovascular disease.

Perhaps one day it will be proven that blood pressure does not correlate with mortality or morbidity, but until then, shouldn't we base our practices on best available evidence? After all, if you will not accept best available evidence, what will you base your practice on?

Monday, March 05, 2007

What is the hurry?

angry doc found this letter to the ST Forum published in January this year (emphasis mine):Cancer vaccine poses risk of degenerative diseasesI REFER to the letter by Ms Karen Tan of the Ministry of Health ('Cervical-cancer vaccine has its limitations'; ST, Jan 9) and the advertisement by Empowered to Protect (The Sunday Times, Jan 7).

We should not rush into advising mothers to protect their daughters against cervical cancer by recommending the anti-cancer vaccine to them. As rightly pointed out by Ms Tan, 'the long-term effectiveness of the vaccine is still not known'.

As the human papillomavirus is transmitted sexually (a sexually-transmitted disease like syphilis and gonorrhoea), mothers should instead teach and advise their daughters (and concerned doctors, their patients) how to protect themselves, e.g., by not exposing themselves to multiple sexual partners and to take other appropriate measures.Aluminium hydroxide is one of the vaccine's components. With three injections over six months, a young girl would have received 675mcg of aluminium. This aluminium will stay in the body, and studies have shown that aluminium is associated with degenerative diseases like Alzheimer's, Lou Gehrig's and even Parkinson's disease.

If you consider having such diseases is better than having cervical cancer, then having the anti-cancer vaccine injection would be your informed choice.

With proper Pap-smear screening programmes, the incidence of cervical cancer in Singapore has been declining over the past 30 years, as Ms Tan mentioned. We should work on this instead of depending on a vaccine that has not weathered the test of time, unless, of course, those who will be having the injection become part of the ongoing experiment to test its efficacy.

There is still doubt about the efficacy of the vaccine, otherwise why should patients who have been vaccinated be advised to continue with Pap-smear screening for cervical cancer?

The Health Sciences Authority should not have approved the use of Gardasil if this doubtexists. What is the hurry?

Dr Tan Soon KiamWhat's the hurry, Dr Tan? Well, if I may quote Associate Professor Tan Huay Cheem of the National University Hospital: 'In real practice, we can't always wait for clinical trial data.'Here is the Ministry of Health's reply to Dr Tan's letter (emphasis mine):Gardasil safe but discuss vaccination with doc firstI REFER to the letter, 'Cancer vaccine poses risk of degenerative diseases' (ST, Jan 11), in which Dr Tan Soon Kiam raised concerns about the safety of aluminium present in vaccines and the basis for the approval of Gardasil by the Health Sciences Authority (HSA).

Aluminium salts have been used widely in vaccines for more than 70 years, as an adjuvant to enhance their efficacy. Their safety record is well-established.

Many scientific and regulatory agencies have reviewed the use of aluminium in vaccines. They have found no sound scientific evidence of long-term adverse effects such as Alzheimer's, Lou Gehrig's or Parkinson's disease.Besides Gardasil, many other commonly-used vaccines contain aluminium. They include vaccines for hepatitis A and B, and immunisations against childhood diseases like diphtheria, tetanus (lockjaw) and pertussis (whooping cough).

As the national regulatory authority for medicinal products, HSA ensures, through a scientific review process, that approved medicinal products in Singapore meet appropriate standards of safety, efficacy and quality.

Several scientific studies have demonstrated that Gardasil is effective for preventing cervical cancer, precancerous lesions and infection caused by sexually-transmitted human papillomavirus (HPV).

Hence, there is sufficient basis to approve this vaccine for the target group of females aged nine to 26 years. Gardasil has also been approved for marketing in the United States, Australia, Canada, Europe and New Zealand.

HSA wishes to emphasise that Gardasil has not been approved for use in the general population. Anyone interested in the vaccination should discuss this with a doctor who will consider factors such as age and personal history of previous exposure to HPVs.

Vaccination does not replace the need for ongoing Pap-smear screening. Healthcare professionals should familiarise themselves with the approved indications and relevant prescribing information on Gardasil to provide the most appropriate advice to patients.

Dr Gerard Wong Deputy Director (Product Evaluation & Registration) Health Products Regulation Group Health Sciences Authority The reply does not tell us that Gardasil does not guarantee 100% protection against HPV infections (no vaccine is 100% protective, Dr Tan), or that not all cervical cancers are caused by the strains of HPV which Gardasil is designed to protect against. That is why Pap smear screening will still be required.The 'vaccine scare' is as old as the practice of vaccination itself, but it certainly has become more widespread in recent years with the availability of internet access. The problem facing the modern parent/patient is not one of lack of information, but one of information overload: how does one decide if the information one is reading is reliable?Can vaccines cause harm? Certainly they can; but so can many diseases which one can now be immunised against. To paraphrase House, pretty much everything in modern medicine is about the risk-benefit ratio; vaccines just happen to be a more emotionally-charged aspect of modern medicine because we give them to babies and in many cases they are compulsory.While doctors need to acknowledge parents' and patients' concern over vaccine safety, we must continue to base our advice and decisions on evidence and science, and not seek to convince our patients with anecdotes and unproven theories.

The writer seeks to espouse chelation therapy for the treatment of coronary artery disease.

We would like to provide a balanced view on this subject on the basis of evidence-based practice. Chelation therapy involves administering intravenous EDTA (a man-made amino acid) infusion over 2-4 hours, given weekly for a total of 30 or more treatments.

The aim of this therapy is to reduce the amount of calcium in atheromatous coronary arteries, hence possibly reducing the arterial narrowings.

There have also been many alternative explanations as to why chelation therapy might work.

Reports of beneficial effects of drugs or devices could be due to subjective and biased reporting, unless they are tested in double blind randomised placebo controlled trials, with an adequate number of patient subjects.

In a 2005 review of the chelation literature by a group of authors from Canada, they found five such randomised trials (see website www.biomedcentral.com/1471-2261-5-32). After going through these trial results, they concluded that the best available evidence does not support the therapeutic use of EDTA chelation therapy in the treatment of atherosclerotic cardiovascular disease. The American Heart Association, American College of Cardiology and the American Food and Drug Administration (FDA), among many other medical organisations, also similarly do not recommend chelation therapy for this indication.

These trials were, however, underpowered for detecting differences in clinical outcomes, as the numbers recruited were too small. Hence, a large US/Canadian multicentre randomised placebo controlled clinical trial, focusing on major clinical outcome endpoints, is currently being carried out by the National Institute of Health, US. The trial is expected to recruit around 2,000 patients, and be completed by June 2010. As the cost of conducting such a trial is at least US$30 million, the National Heart Centre will not be in a position to perform such a trial, given its prohibitive cost.

We should therefore await the results of this NIH-sponsored trial before recommending such unproven therapy to our patients. This is especially so when there are already very effective proven therapy for atherosclerotic cardiovascular disease, in terms of drugs, bypass surgery and coronary stenting.

Chelation therapy has also been reported to have rare side-effects of sudden blood pressure drop, abnormally low calcium levels in the blood and kidney damage and it may affect blood cell production.

A/Prof Koh Tian HaiMedical DirectorNational Heart Centreangry doc notes the contrast between Prof Koh's letter and that from Dr Tan, the one neutral in tone and referring to specific paper and website, and the other emotive and providing only anecdotes.He also notes that, judging from the titles he gave the to the two letters, the ST Forum editor probably does not know the difference between drug-eluting stent and EDTA chelation therapy.Unfortunately, there are already doubts about the objectivity of the NIH/NCCAM study before it is even concluded.For a start, the theory that chelation therapy works by '[reducing] the amount of calcium in atheromatous coronary arteries, hence possibly reducing the arterial narrowings' is itself dubious to begin with (as are some of the 'alternative explanations') and has not been shown to be true in (just) one animal study, the blinding during the therapy may be less than perfect, and as mentioned in a previous post there may be reasons to suspect bias from some of the centres where the trial is being carried out.All that is not to say that the study will not be fair or that it will not show any benefit of chelation therapy, but it does seem a pity that a study that will involve so many patients and so much funds should have so many doubts cast on it even in such an early stage.

Friday, March 02, 2007

To write is to sit in judgement on oneself

A thought-provoking post at Dr RW's blog today sends angry doc on a bit of introspection...Long-time readers may remember that angry doc blogged about the issue of new guidelines on hypertension previously.angry doc was brought up in the era of the 'J-curve': the concept that there exists a 'normal' range for blood pressure; go above or below that range, and your risk of mortality and morbidity increases correspondingly. But now that idea seems no longer valid, with studies concluding that there is 'no patient group among whom more intensive BP lowering would not be expected to produce greater risk reductions' and that '[t]hroughout middle and old age, usual blood pressure is strongly and directly related to vascular (and overall) mortality, without any evidence of a threshold down to at least 115/75 mm Hg'.angry doc must confess to feeling discomfited by such studies, but it is unscientific to dismiss evidence without valid reasons as to why they are flawed, or without evidence that shows the contrary.The point of this post, however, is not about what the 'healthy' range of blood pressure is, but that sense of discomfiture which reveals to angry doc his own prejudices: we all have our 'comfort zones' when it comes to health beliefs, and sometimes it can feel unpleasant when these beliefs are challenged.But if angry doc is to practise what he preaches, he must assess the evidence presented and, if he can find no fault in them or evidence to the contrary, accept them and see how they should be applied in his practice.As he has said, it is not a pleasant feeling, but nevertheless he finds comfort in a progressive system where evidence continues to be collected and studied, and change, when warranted, can be implemented.Besides, he is pretty sure the 'J-curve' will be proven to be correct again some day... afterall, a blood pressure of 0/0mmHg can't be good for you!

Thursday, March 01, 2007

"Fallen"

Heaven bent to take my handAnd lead me through the fireBe the long awaited answerTo a long and painful fightTruth be told I've tried my bestBut somewhere along the wayI got caught up in all there was to offerBut the cost was so much more than I could bearHeaven bent to take my handI've nowhere left to turnI'm lost to those I thought were friendsTo everyone I knowOh they turn their heads embarrassedPretend that they don't seeThat it's one missed step one slip before you know itAnd there doesn't seem a way to be redeemed- Sarah McLachlan